NATIONAL COVID-19 VACCINATION OPERATIONS CENTER

Philippine International Convention Center, Vicento St., Pasay City, Metro Manila

9 September 2021

ADVISORY NO. 86
Philippine COVID-19 Vaccine Deployment and Vaccination Campaign

Improving Vaccination Technique in the Administration of COVID-19 Vaccines

This Advisory is issued to inform all Regional/Local Vaccination Operation Centers

(R/LVOCs), Implementing Units, Vaccination Sites on the updates of the investigation relative
to the reported black particles in Pfizer-BioNTech COVID-19 vaccines, and to provide
guidance on the administration of these vaccines.

The Food and Drug Administration (FDA) has communicated the results of the
investigation on the reported black particles in the Pfizer-BioNTech COVID-19 vaccines to the
National Vaccination Operations Center (NVOC) after forwarding this concern to the the
manufacturer, Pfizer Global Supply (in Puurs, Belgium).

Pfizer Global Supply concludes the reported black particles in the Pfizer-BioNTech
COVID-19 vaccines are not representative of the quality of the batch and the batch
remains acceptable. The most probable root cause for this occurrence is related to rubber
originating from the stopper of the vial.

The presence of rubber stopper particles inside the solution may have come from incorrect
technique during product preparation. To ensure proper Pfizer-BioNTech vaccines preparation,
all vaccination teams shall:

1. Insert the needle in the center ring of the top plug.

2. Ensure that the needle does not scrape the rubber off the inner wall of the small channel
of the stopper and is inserted vertically.

3. Do not rotate or twist during the piercing of the stopper to avoid producing a particle
being cored out. This usually occurs when a wider bore needle is being used.

4. Use only 21G or narrower needle for mixing the Pfizer-BioNTech vaccines or adding
a diluent.

5. Always do physical examination and check for discoloration and presence of particulate
matter during the preparation and before administration of any COVID-19 vaccine.

All RVOCs, LVOCs and Implementing Units are instructed to ensure the
implementation of this Advisory. For any issues and concerns related to this Advisory, you
may email to c19vaccineopcen@gmail.com.
This Advisory is effective immediately, and for wide dissemination and compliance.

MYRNA C. CABOTAJE, MD, MPH, CESO III

Chair, National Vaccination Operations Center
Undersecretary of Health, Field Implementation and Coordination Team
Department of the Health